Ostomy Appliance

ABSTRACT

An ostomy appliance comprising: first and second walls connected to each other at or near their peripheries, the first wall having a stoma-receiving opening; a connection member connected to the first wall for attaching the appliance to a user; an aperture located in either of the first and/or second walls for permitting waste gases to exit the appliance; and a multi-layer filter positioned adjacent and covering the aperture on an exterior surface of the respective first and/or second wall. A layer of the filter is hydrophobic and the hydrophobic layer is positioned directly adjacent the respective first and/or second wall. The hydrophobic layer has a first side and a second side, where the first side is connected directly to the respective first and/or second wall, and the connection holds the multi-layer filter relative to the wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/649,070, filed Mar. 19, 2020, which is a U.S. National StageApplication filed under 35 U.S.C. § 371 of International Application No.PCT/GB2018/052688, filed Sep. 21, 2018, which claims the benefit ofGreat Britain Application No. 1715388.3, filed Sep. 22, 2017. All ofthese applications are hereby incorporated by reference in theirentireties.

BACKGROUND OF THE INVENTION

The invention relates to an ostomy appliance for collecting human waste.It should be understood that the invention can be utilised in drainableand non-drainable ostomy appliances.

It is known to provide in a wall of an ostomy appliance (bag′ or ‘pouch’as they are commonly known in the art) an aperture to permit waste gasesto escape from a waste collecting chamber of the ostomy appliance. Thisis necessary to prevent the bag expanding too much with gas andpotentially from leaking or bursting whilst filled with waste. In someprior art ostomy appliances the aperture is covered by a filter, thepurpose of which is to de-odorise the waste gases before they exit toatmosphere. In the known ostomy appliances the aperture and filter areusually positioned in an upper part of the bag above a stoma receivingopening. Such filters are usually, but not always, positioned inside theexterior wall of ostomy appliance so that waste gas must pass throughthe filter before exiting the bag via the aperture.

Although intermediate walls are often provided in between the exteriorwalls in order to create a tortuous path for waste gas to travel throughin order to get to the filter, thus making it difficult for bodily wasteto come into contact with the filter, these walls are quite oftenunsuccessful in keeping bodily waste away from the filter. In this case,the filter can become blocked during use which causes the appliance togradually inflate with waste gases with no means of escaping, causingdiscomfort and/or embarrassment to the user.

The present invention looks to address this problem.

SUMMARY OF THE INVENTION

According to a first aspect of the invention, we provide an ostomyappliance comprising:

-   -   first and second walls connected to each other at or near their        peripheries, the first wall having a stoma-receiving opening;    -   a connection member connected to the first wall for attaching        the appliance to a user;    -   an aperture located in either of the first and/or second walls        for permitting waste gases to exit the appliance;    -   a multi-layer filter positioned adjacent and covering the        aperture on an exterior surface of the respective first and/or        second wall,    -   wherein a layer of the filter is hydrophobic and wherein said        hydrophobic layer is positioned directly adjacent the respective        first and/or second wall, wherein the hydrophobic layer has a        first side and a second side and wherein the first side is        connected directly to the respective first and/or second wall,        said connection holding the multi-layer filter relative to the        wall.

Further features of the first aspect of the invention are set out in theclaims as appended hereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the invention will now be described by way of exampleonly with reference to the accompanying drawings, of which:—

FIG. 1 is a front view of a first embodiment of an ostomy appliance inaccordance with the present invention;

FIG. 2 is a side cross-sectional view of the ostomy appliance of FIG. 1;

FIG. 3 is a further side cross-sectional view of the ostomy appliance ofFIG. 1 ;

FIG. 4 is a front view of a second embodiment of an ostomy appliance inaccordance with the present invention;

FIG. 5 is a side cross-sectional view of the ostomy appliance of FIG. 4;

FIG. 6 is a further side cross-sectional view of the ostomy appliance ofFIG. 4 ; and

FIG. 7 is a perspective view of an example of a multi-layer filter foruse in the first and second embodiments of ostomy appliance.

DETAILED DESCRIPTION OF THE INVENTION

Referring firstly to FIGS. 1 to 3 these show a first embodiment of anostomy appliance in accordance with the present invention, showngenerally at 10. The general construction of the ostomy appliance 10 issimilar to those well known in the art and in that sense it includesfirst 11 and second 12 walls which are connected to each other at ornear their peripheries, for example by welding or using an adhesive. Theostomy appliance 10 shown could be a drainable appliance, meaning thatits contents could be emptied through an outlet (50, shown in brokenlines) between the first 11 and second 12 walls.

The first wall 11 has a stoma-receiving opening 13 and is connected to agenerally circular connection member 14 in the form of a flange foradhering the appliance 10 to a user around their stoma. The connectionmember 14 could be any appropriate shape, however.

The ostomy appliance 10 defines at least one chamber therein. A wastecollecting chamber 30 is provided which communicates with thestoma-receiving opening 13 and, if the ostomy appliance is a drainableappliance, at its lower end with an outlet (50). The waste collectingchamber 30 is defined between the first 11 and second 12 walls and isprovided as the primary chamber for collecting a user's waste, whichenters the chamber through the opening 13 in the first wall 11. Morechambers (not shown) may be provided within the ostomy appliance, forexample in order to create a tortuous path for the waste gas to exit theappliance and/or to allow fluid in a further chamber to pass into thewaste collecting chamber 30 via a non-return valve.

An aperture 15 is provided in the second wall 12 to permit waste gaswithin the ostomy appliance 10 to exit the appliance. The aperture 15 ispreferably in use provided above the stoma-receiving opening 13 toreduce the likelihood of waste collected in the waste collecting chamber30 from getting near to the aperture 15. The aperture 15 is preferablycircular in shape but can be formed in a number of different shapes. Theaperture 15 could in some embodiments of the present invention include aplurality of apertures in the form of perforations provided in thesecond wall 12. Although the aperture 15 is shown in FIG. 1 as beingprovided in the second wall 12, it may instead be provided in the firstwall 11. Alternatively, apertures may be provided on both the first 11and second 12 walls.

A filter 20 is provided externally of the ostomy appliance 10 as shownin FIGS. 1 and 2 . More specifically the filter 20 is attached to anexterior surface of the second wall 12. The filter is attached to thesecond wall 12 adjacent the aperture 15 so that the aperture is fullycovered by the filter 20. It can be seen on FIG. 1 that the aperture 15is a smaller diameter than the diameter of the filter 20. Therefore, anywaste gases that exit the ostomy appliance 10 through the aperture 15must pass through the filter 20 in order to pass to atmosphere. Thefilter 20 is attached by an adhesive connection, although it could beconnected in any appropriate way, for example heat welding.

The filter 20 is a multi-layered filter as shown in more detail in FIG.7 . The multi-layered filter 20 preferably consists of three layers(although it could have more layers), including a hydrophobic layer 21,a de-odorising layer 22 and a gas and liquid impermeable layer 23. Themulti-layered filter 20 is preferably constructed (but not limited to)in the order of hydrophobic layer 21, de-odorising layer 22 and gas andliquid impermeable layer 23.

The hydrophobic layer 21 is preferably Polytetrafluoroethylene (PTFE).The hydrophobic nature of PTFE ensures that water molecules are repelledfrom its surface, meaning that any interaction between the surface ofthe PTFE layer and water molecules is substantially resisted, and thus,the PTFE layer is waterproof. The hydrophobic layer 21 of themulti-layered filter 20 is advantageously positioned directly adjacentthe second wall 12 so as to directly and completely cover the aperture15 provided in the second wall 12. The hydrophobic layer 21 has a firstside and second side with the first side connected directly to thesecond wall 12, said connection holding the multi-layer filter relativeto the wall 12. The hydrophobic layer 21 is connected directly to thesecond wall 12 preferably by an adhesive, e.g. a holt melt adhesive ordouble-sided tape. Therefore, the hydrophobic layer 21 is in directfluid communication with the waste collecting chamber 30 such that anywaste gas exiting the ostomy appliance 10 must travel through thehydrophobic layer 21 first. The advantage of providing the hydrophobiclayer 21 directly adjacent the aperture 15, and thus facing inwardstowards the interior of the appliance is that no liquid waste collectedin the waste collecting chamber 30 can pass through the hydrophobiclayer 21 and into contact with the other layers of the multi-layeredfilter 20. This reduces the risk of the filter, in particular thede-odorising layer 22, from getting damp and/or clogged. A damp and/orclogged filter can lead to ballooning of the ostomy appliance which cansignificantly reduce the effectiveness of the filter and the appliance.This will inevitably lead to the user having to replace the flawedostomy appliance at a cost to the user.

Further to this, the multi-layered filter 20 is advantageouslypositioned on an external surface of the second wall 12 such that thede-odorising layer 22 and gas and liquid impermeable layer 23 cannotcome into direct contact with the waste collected in the wastecollecting chamber which significantly reduces the risk of the filter 20from getting damp and/or clogged. Further to this, providing a filter 20externally of the ostomy appliance 10, e.g. external of the wall orwalls which form the waste collecting chamber, allows for an easier andthus more cost effective manufacturing process as there is no need toplace the filter carefully between layers of the ostomy appliance beforethey are connected together. Instead, the filter 20 can, if desired, beattached to the ostomy appliance once the walls of the appliance havebeen sealed together around its peripheries.

The de-odorising layer 22 is preferably a layer of carbon basedde-odorising material that is positioned directly adjacent thehydrophobic layer 21 such that it lies on an opposite side of thehydrophobic layer 21 to the aperture 15 and wall 12. The de-odorisinglayer 22 receives waste gas travelling from the hydrophobic layer 21 andde-odorises the waste gas such that it is ready to exit the de-odorisinglayer 22 into atmosphere.

The gas and liquid impermeable layer 23 is preferably a layer ofCryovac™ material that does not allow gas or liquid to pass through itssurface. The gas and liquid impermeable layer 23 is positioned directlyadjacent the de-odorising layer 22 such that it lies on an opposite sideof the de-odorising layer 22 to the hydrophobic layer 21. The gas andliquid impermeable layer 23 advantageously partially protects thede-odorising layer 22 from getting damp and/or clogged by moisture thatis provided externally of the ostomy appliance, for example when a useris showering.

Referring to FIG. 3 , arrows 24, 25 show the directional flow path takenby waste gas when exiting the waste collecting chamber 30 through thefilter 20. Firstly, the waste gas travels through the aperture 15 andinto the hydrophobic layer 21 in a direction substantially perpendicularto the second wall 12. Thereafter the waste gas continues to travelthrough the hydrophobic layer 21 and into the de-odorising layer 22 in adirection substantially perpendicular to the second wall 12. Finally,the waste gas travels through and exits the de-odorising layer 22 in adirection substantially parallel to the second wall 12, i.e. radiallyaway from an axis of the filter 20. The positioning of the gas andliquid permeable layer 23 directly adjacent the de-odorising layer 21ensures that all gas entering the filter passes through the de-odorisinglayer in a direction substantially parallel to the second wall 12.

FIGS. 4 to 6 show a second embodiment of an ostomy appliance 110.Features which are in common with the first embodiment 10 have beengiven the same reference numeral with the addition of 100. Thosefeatures will not be discussed again here.

Referring to the second embodiment the main difference is the size ofthe aperture 115 in relation to the multi-layered filter 120. Instead ofthe aperture 115 being significantly smaller in diameter than the filter120, the aperture 115 is substantially the same diameter as the filter120. This provides for an increased area through which the waste gas canexit the ostomy appliance through the aperture 115 and into and throughthe hydrophobic layer 121 and further reduces the risk of the aperture115 becoming completely blocked with waste. The flow through theaperture 115 and multi-layered filter 120 is substantially the same asthat of the first embodiment, as shown by arrows 124, 125.

Whilst in the described embodiments the filter is shown as circular infront view, it should be appreciated that other shapes of filter couldbe used without departing from the scope of the present invention. Inaddition, whilst the filter described above has three layers, it shouldbe appreciated that a two layer filter could be used, but also filtersof four or more layers could be used.

When used in this specification and claims, the terms “comprises” and“comprising” and variations thereof mean that the specified features,steps or integers are included. The terms are not to be interpreted toexclude the presence of other features, steps or components.

The features disclosed in the foregoing description, or the followingclaims, or the accompanying drawings, expressed in their specific formsor in terms of a means for performing the disclosed function, or amethod or process for attaining the disclosed result, as appropriate,may, separately, or in any combination of such features, be utilised forrealising the invention in diverse forms thereof.

ASPECTS OF THE INVENTION

Various aspects of the inventions described above are set out in thefollowing clauses.

Aspect 1: An ostomy appliance comprising:

-   -   first and second walls connected to each other at or near their        peripheries, the first wall having a stoma-receiving opening;    -   a connection member connected to the first wall for attaching        the appliance to a user;    -   an aperture located in either of the first and/or second walls        for permitting waste gases to exit the appliance;    -   a multi-layer filter positioned adjacent and covering the        aperture on an exterior surface of the respective first and/or        second wall,    -   wherein a layer of the filter is hydrophobic and wherein said        hydrophobic layer is positioned directly adjacent the respective        first and/or second wall,    -   wherein the hydrophobic layer has a first side and a second side        and wherein the first side is welded directly to the respective        first and/or second wall, said connection holding the        multi-layer filter relative to the wall.

Aspect 2: An appliance according to clause 1 wherein the hydrophobiclayer is polytetrafluoroethylene (PTFE).

Aspect 3: An appliance according to any preceding clause wherein thefirst side of the hydrophobic layer is connected directly to therespective first and/or second wall by an adhesive, e.g. a hot meltadhesive or double-sided tape.

Aspect 4: An appliance according to any preceding clause wherein thefilter includes a de-odorising layer positioned adjacent the hydrophobiclayer.

Aspect 5: An appliance according to any preceding clause wherein thede-odorising layer is preferably carbon based.

Aspect 6: An appliance according to any preceding clause wherein thefilter includes a gas and liquid impermeable layer positioned adjacentthe de-odorising layer.

Aspect 7: An appliance according to clause 6 wherein the gas and liquidimpermeable layer is preferably cryovac material.

Aspect 8: An appliance according to any preceding clause wherein thelayers of the filter are arranged in the order of hydrophobic layer,de-odorising layer and gas and liquid impermeable layer.

Aspect 9: An appliance according to clause 8 wherein the de-odorisinglayer is positioned directly adjacent the hydrophobic layer and whereinthe gas and liquid impermeable layer is positioned directly adjacent thede-odorising layer.

Aspect 10: An appliance according to any preceding clause wherein wastegas travels through the aperture in a direction substantiallyperpendicular to the first and/or second wall.

Aspect 11: An appliance according to any preceding clause wherein wastegas travels through the hydrophobic layer in a direction substantiallyperpendicular to the first and/or second wall.

Aspect 12: An appliance according to any preceding clause wherein wastegas travels through the de-odorising layer in a direction substantiallyparallel to the first and/or second wall.

Aspect 13: An appliance according to clause 12 wherein the gas andliquid impermeable layer is configured to ensure that all gas enteringthe filter passes through the de-odorising layer in a directionsubstantially parallel to the first and/or second wall.

1. An ostomy appliance comprising: first and second walls connected toeach other at or near their peripheries, the first wall having astoma-receiving opening; a connection member connected to the first wallfor attaching the appliance to a user; an aperture located in either ofthe first and/or second walls for permitting waste gases to exit theappliance; a multi-layer filter positioned adjacent and covering theaperture on an exterior surface of the respective first and/or secondwall, said multi-layer filter having only two layers, wherein a firstlayer of the filter is hydrophobic and wherein said hydrophobic layer ispositioned directly adjacent the respective first and/or second wall,and wherein the hydrophobic layer has a first side and a second side andwherein the first side is connected directly to the respective firstand/or second wall, said connection holding the multi-layer filterrelative to the wall.
 2. The appliance according to claim 1 wherein thehydrophobic layer is polytetrafluoroethylene (PTFE).
 3. The applianceaccording to claim 1 wherein the first side of the hydrophobic layer isconnected directly to the respective first and/or second wall by anadhesive.
 4. The appliance according to claim 1 wherein a second layerof the filter is a de-odorising layer positioned adjacent thehydrophobic layer.
 5. The appliance according to claim 1 wherein thede-odorising layer is carbon based.
 6. The appliance according to claim1 wherein waste gas is able to travel through the aperture in adirection substantially perpendicular to the first and/or second wall.7. The appliance according to claim 1 wherein waste gas is able totravel through the hydrophobic layer in a direction substantiallyperpendicular to the first and/or second wall.
 8. The applianceaccording to claim 1 wherein waste gas is able to travel through thede-odorising layer in a direction substantially parallel to the firstand/or second wall.
 9. The appliance according to claim 1 wherein thefirst side of the hydrophobic layer is welded.
 10. The applianceaccording to claim 1 wherein the first and second walls are connected toeach other at their peripheries by welding.
 11. The appliance accordingto claim 1 wherein the aperture is positioned in a top half of theappliance.
 12. The appliance according to claim 1 wherein the apertureis positioned above the stoma-receiving opening, optionally directlyabove the stoma-receiving opening.
 13. The appliance according to claim1 wherein the aperture and/or filter is circular in shape.
 14. Theappliance according to claim 1 including a plurality of apertures,wherein the multi-layer filter is positioned adjacent and covers eachaperture.
 15. The appliance according to claim 14 wherein the aperturesare provided in the form of perforations in the second wall.
 16. Theappliance according to claim 1 wherein the multi-layer filter fullycovers the aperture.
 17. The appliance according to claim 1 wherein theaperture is smaller than the filter.
 18. The appliance according toclaim 1 wherein the aperture is substantially the same size and/ordiameter as the filter.
 19. The appliance according to claim 1 whereinthe first and second walls define a waste collecting chamber; andwherein the hydrophobic layer is in direct fluid communication with thewaste collecting chamber.
 20. The appliance according to claim 1 whereinthe first and second walls define a waste collecting chamber; andwherein the filter is provided external of the first wall and/or secondwall which define the waste collecting chamber.